A Phase 1, Open-label, Multicenter Study of BMS-936564 (MDX-1338) in Subjects With Relapsed Acute Myelogenous Leukemia and Selected B-cell Malignancies
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability as monotherapy
Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities
Within the first 7 days for AML
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA212-001
NCT01120457
August 2010
September 2013
Name | Location |
---|---|
University of Washington School of Medicine | Seattle, Washington 98195 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Local Institution | Springfield, Massachusetts |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Ucla-Division Of Hematology/Oncology | Los Angeles, California 90095 |
Usc - Norris Comprehensive Cancer Center And Hospital | Los Angeles, California 90033 |
B. Douglas Smith, M.D. | Baltimore, Maryland 21287 |